Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) (BLAST)
The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)|
- Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle [ Time Frame: During the first cycle (6 weeks) ] [ Designated as safety issue: No ]
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.
Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.
- Hematological Relapse-free Survival Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant [ Time Frame: 100 days after HSCT ] [ Designated as safety issue: No ]
- Time to Hematological Relapse [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Duration of Complete MRD Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- MRD Level [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Number of Participants With Adverse Events [ Time Frame: Adverse events are reported until the data cut-off date of 21 February 2014; the median treatment duration was 52 days. ] [ Designated as safety issue: Yes ]
Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.
The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.
- Quality of Life [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Resource Utilization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||January 2019|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
Continuous intravenous infusion
The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against CD19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.
Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occurr until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207388
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|Principal Investigator:||Ralf Bargou, MD||Medizinische Klinik und Poliklinik II, Würzburg|
|Principal Investigator:||Nicola Gökbuget, MD||Klinikum der Goethe Universität Frankfurt|